Transcranial Direct-Current Stimulation (tCDS) and Robotics for Children With Hemiplegia

NCT03145532 | Unknown

• 1 other identifier: 16-1003KF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hemiplegia occurs when the function of motor areas in the brain become impaired, predominantly unilaterally, during perinatal development. Children with hemiplegia show impairments in motor control of the affected side of the body. Impairments in use of the upper extremity are common, and lead to functional disability throughout the lifespan of a person with hemiplegia. Upper extremity impairments can severely affect a person's ability to carry out activities of daily living. The goal of this study at Blythedale Children's Hospital is to test the efficacy of transcranial direct current stimulation (tDCS) and robotic upper extremity therapy in improving upper extremity function in children with unilateral cerebral palsy. This study will test the hypothesis that physical rehabilitation, provided by repetitive arm movements guided by a robot, will improve upper extremity function in children with hemiplegia, and that this improvement can be enhanced by transcranial direct current stimulation of motor cortex immediately before robotic training.

Conditions

Cerebral Palsy; Hemiplegia

Outcome Measures

Primary Outcomes (3)

• Change in Assisting Hand Assessment after intervention

  Assessment of how well children incorporate both hands into bimanual task performance, using an assessment tool called the "Assisting Hand Assessment"

  Within one week after the intervention ends

• Change in Jebsen-Taylor Test of Hand Function after intervention

  Assessment of unimanual movement speed

  Within one week after the intervention ends

• Change in Box and blocks test after intervention

  Assessment of unimanual function

  Within one week after the intervention ends

Study Arms (2)

Real tDCS plus robotic training

EXPERIMENTAL

Children will receive 20 min of real tDCS stimulation per session, followed by robotic training for 1 hr.

Other: tDCS plus robotic training

Sham tDCS plus robotic training

SHAM COMPARATOR

Children will receive 20 min of sham tDCS stimulation per session, followed by robotic training for 1 hr.

Other: tDCS plus robotic training

Interventions

tDCS plus robotic training OTHER

Children will first receive 20 min of tDCS (real or sham, see Arms), then will receive 1 hr of upper limb robotic therapy in which the child will use their impaired arm and hand to move a joystick controlling a cursor to a set of targets on a video screen in front of the child.

Real tDCS plus robotic training; Sham tDCS plus robotic training

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-17
• Participant and caregiver willing and able to provide informed consen/assent
• Diagnosis of hemiplegia
• Joint mobility: wrist extension, 20º, metacarpophalangeal and proximal interphalangeal joints 10º

You may not qualify if:

• Cognitive deficits that impede understanding of study protocol
• Current medical illness unrelated to CP
• Visual problems (uncorrected by glasses/contact lenses)
• High motor ability in affected arm Pre-intervention screening measures; Motor activity log, score \> 2.5 ( \> slight-to-moderate)
• Severe spasticity Pre-intervention screening measures; Modified Ashworth test, score \> 3 ( \> moderate)
• Lack of asymmetry in hand function
• Orthopedic surgery in affected arm within 2 years
• Dorsal root rhizotomy
• Botulinum toxin therapy in either upper extremity during last 2 months, or planned during study period
• Currently receiving intrathecal baclofen
• Seizure beyond age 2, use of anti-seizure medication, history of epilepsy (in self or first degree relatives), brain surgery, cranial metal implants, structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
• True positive response on the Transcranial Magnetic Stimulation Safety Screen
• Current use of medications known to lower the seizure threshold
• Previous episode of neurocardiogenic syncopy

Sponsors & Collaborators

• Blythedale Children's Hospital: lead

Study Sites (1)

Kathleen Friel

Valhalla, New York, 10605, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: tDCS will be blinded in that even children in the sham group will receive a low level of stimulation for a brief period.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cerebral Palsy Research

Model Details: Children will be randomized to receive either real or sham tDCS plus robotic training. Children in the sham group will be given the opportunity to repeat the protocol and receive real stimulation after they complete the sham protocol.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 9, 2017
• Study Start: June 12, 2017
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)